Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06513949
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-27
Brief Title:
Anti-CD14 Treatment With IC14 in Hospitalized ARDS Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase 2 Randomized Double-Blind Placebo-Controlled Safety and Efficacy Study of Anti-CD14 Treatment With a Recombinant Chimeric Monoclonal Antibody IC14 in Hospitalized Patients With Acute Respiratory Distress Syndrome
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hospitalized patients with ARDS will be randomized to intravenous treatment with a monoclonal antibody against CD14 called IC14 or placebo They will be followed for 28 days
The primary outcome is the day 4 oxygenation index assessed as a continuous measure
The primary outcome is the day 4 oxygenation index assessed as a continuous measure
Detailed Description:
This is a phase 2 randomized double-blind placebo-controlled safety and efficacy study of anti-CD14 treatment with a recombinant chimeric monoclonal antibody IC14 in hospitalized patients with Acute Respiratory Distress Syndrome ARDS CD14 is a key mediator in recognition of molecular markers of tissue damage damage-associated molecular patterns DAMPs and infection pathogen-associated molecular patterns PAMPS
The primary objective of the study is to determine the efficacy of IC14 in patients hospitalized with ARDS for reducing the severity of lung injury as measured by the day 4 Oxygenation Index OI assessed as a continuous measure mean airway pressure x fraction of inspired oxygen FiO2 x 100partial pressure of oxygen PaO2 OI captures severity of hypoxemia and concurrent intensity of ventilatory support
Secondary objectives include determining whether IC14 reduces the systemic and alveolar inflammatory response and improves indices of oxygenation and illness severity Exploratory endpoints include determining the effect of CD14 blockade on duration of mechanical ventilation and mortality in patients hospitalized with ARDS Pharmacokinetic PKPharmacodynamic PD endpoints include determining day 4 IC14 levels in bronchoalveolar fluid BALF vs serum and determining the feasibility of measuring blood presepsin levels a CD14-pathway specific biomarker for rapid assessment
The primary objective of the study is to determine the efficacy of IC14 in patients hospitalized with ARDS for reducing the severity of lung injury as measured by the day 4 Oxygenation Index OI assessed as a continuous measure mean airway pressure x fraction of inspired oxygen FiO2 x 100partial pressure of oxygen PaO2 OI captures severity of hypoxemia and concurrent intensity of ventilatory support
Secondary objectives include determining whether IC14 reduces the systemic and alveolar inflammatory response and improves indices of oxygenation and illness severity Exploratory endpoints include determining the effect of CD14 blockade on duration of mechanical ventilation and mortality in patients hospitalized with ARDS Pharmacokinetic PKPharmacodynamic PD endpoints include determining day 4 IC14 levels in bronchoalveolar fluid BALF vs serum and determining the feasibility of measuring blood presepsin levels a CD14-pathway specific biomarker for rapid assessment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None